Human T-cell lymphotropic virus (HTLV-III), lymphadenopathy-associated virus (LAV), or AIDS-associated retrovirus (ARV) has been identified as the cause of acquired immune deficiency syndrome (AIDS) (Popovic, M., Sarngadharan, M. G., Read, E. and Gallo, R. C., [1984] Science 224:497-500). The virus displays tropism for the OKT4.sup.+ lymuhocyte subset (Klatzmann, D., Barre-Sinoussi, F., Nugeyre, M. T., Dauguet, C., Vilmer, E., Griscelli, C., Brun-Vezinet, F., Rouzioux, C., Gluckman, J. C., Chermann, J. C. and Montagnier, L. [1984] Science 225:59-63). Antibodies against HTLV-III proteins in the sera of most AIDS and AIDS related complex (ARC) patients, and in asymptomatic people infected with the virus (Sarngadharan, M. G., Popovic, M., Bruch, L., Schupbach, J. and Gallo, R. C. [1984] Science 224:506-508) have made possible the development of immunologically based tests that detect antibodies to these antigens. These tests are used to limit the spread of HTLV-III through blood transfusion by identifying blood samples of people infected with the virus. Diagnostic tests currently available commercially use the proteins of inactivated virus as antigens.
In addition to allowing new approaches for diagnosis, recombinant DNA holds great promise for the development of vaccines against both bacteria and viruses (Wilson, T. [1984] Bio/Technology 2:29-39). The most widely employed organisms to express recombinant vaccines have been E. coli, S. cerevisiae and cultured mammalian cells. For example, subunit vaccines against foot and mouth disease (Kleid, D. G., Yansura, D., Small, B., Dowbenko, D., Moore, D. M., Brubman, M. J., McKercher, P. D., Morgan, D. O., Robertson, B. H. and Bachrach, H. L. [1981] Science 214:1125-1129) and malaria (Young, J. F., Hockmeyer, W. T., Gross, M., Ripley Ballou, W., Wirtz, R. A., Trosper, J. H., Beaudoin, R. L., Hollingdale, M. R., Miller, L. M., Diggs, C. L. and Rosenberg, M. [1985] Science 228:958-962) have been synthesized in E. coli. Other examples are hepatitis B surface antigen produced in yeast (McAleer, W. J., Buynak, E. B., Maigetter, R. Z., Wampler, D. E., Miller, W. J. and Hilleman, M. R. [1984] Nature 307: 178-180) and a herpes vaccine produced in mammalian cells (Berman, P. W., Gregory, T., Chase, D. and Lasky, L. A. [1984] Science 227:1490-1492).
There is a real need at this time to develop a vaccine for AIDS. No such vaccine is known to exist.